Regulatory Affair Specialist

About the Company: Our client is a global leader in producing high-tech medical and aesthetic devices, known for their use of valuable materials and sophisticated design. With offices and manufacturing facilities in the USA, UK, Bratislava, India, and other countries, this international company is at the forefront of innovation in its field.

Job Overview: As a Regulatory Affairs Specialist, you will play a crucial role in ensuring that our client’s medical devices comply with all applicable regulations and standards across various markets. This role requires close collaboration with regulatory bodies, internal departments, and customers to manage product registrations, maintain technical documentation, and support compliance processes. Your work will directly contribute to the global market access of innovative medical and aesthetic devices, ensuring product safety and regulatory integrity.

Key Responsibilities:

• Ensure regulatory compliance of medical devices across different countries
• Coordinate and prepare product registrations and notifications within deadlines
• Communicate with regulatory authorities for product registrations and updates
• Prepare and maintain technical files and other regulatory documents
• Legalize documents and certificates through notary offices and embassies for product approvals
• Provide support to customers with product data and regulatory information
• Ensure compliance for product exports, including managing Certificates of Origin
• Collaborate with marketing, purchasing, and engineering teams to meet regulatory requirements
• Handle the issuance of Free Sale Certificates and other required regulatory documents
• Support the registration of Economic Operators in the EUDAMED database
• Translate regulatory documents between Slovak and English when necessary
• Ensure compliance with organizational quality, environment, and health and safety standards

Requirements:

• Academic degree in life sciences, chemistry, or technical/engineering education
• 2+ years of experience in a similar regulatory affairs position
• Knowledge of regulatory issues and experience interfacing with local and international regulatory bodies
• Advanced computer skills (MS Office)
• Experience in medical writing is an advantage
• English: Advanced (C1)
• Slovak: Proficiency (C2)

Other Skills:

• High attention to detail
• Strong analytical and organizational skills
• Excellent writing and communication skills
• Team player with strong interpersonal abilities

What We Offer:

• Competitive salary
• 13th salary in Q1 based on both company profits and individual employee performance
• Reimbursement for commuting expenses
• Great office environment and team culture
• Long-term contract with the potential for growth
  

Join us and contribute to creating innovative products in a fast-paced, global environment!

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